Closure system and uses thereof

ABSTRACT

The present invention relates generally to a closure system for use in surgical procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. provisional patentapplication Ser. Nos. 61/291,132, filed Dec. 30, 2009, and 61/299,974,filed Jan. 30, 2010, the entirety of each of which is herebyincorporated herein by reference. The present application is adivisional application of U.S. non-provisional patent application Ser.No. 12/982,852, filed Dec. 30, 2010, which is hereby incorporated hereinby reference.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to a closure system for use insurgical procedures.

BACKGROUND

Minimally invasive procedures are continually increasing in number andvariation in part because such techniques offer an immediate advantageover more traditional, yet highly invasive surgeries. Endoscopicsurgery, for example, uses one or more scopes inserted through smallincisions for diagnosing and treating disease. In particular,endovascular surgery gives access to many regions of the body, such asthe heart, through major blood vessels. Typically, the techniqueinvolves introducing a surgical instrument percutaneously into a bloodvessel, such as, for example, the femoral artery. The currently emergingpercutaneous endovascular procedures include aortic valve replacement,mitral valve repair, abdominal and thoracic aneurysm repair andtricuspid valve replacement. Other procedures requiring access to thefemoral artery include coronary, carotid and cerebral angiographicprocedures.

A key feature of these minimally invasive surgical procedures is theforming of a temporary pathway, usually an incision, to the surgicalsite. For example, in the emerging percutaneous endovascular procedures,an access site (e.g. incision) ranging from approximately 10 to 30French units is formed as a temporary pathway to access the surgicalsite. Various instruments, such as procedural sheaths, guidewires andcatheters, are then inserted through the access site, as well asspecialized medical instruments, such as, balloon catheters and stents.

Currently, incision or access sites are routinely closed via cut-downsurgical repair. This method is very invasive and fraught withcomplications. Accordingly, the rapid development of percutaneousendovascular surgery, of which interventional radiology and cardiologyare a major component, has led to the need for instrumentation tominimize the risk of complications associated with closing the accesssite after a procedure.

SUMMARY OF THE INVENTION

The present invention provides a minimally invasive surgical closuresystem. In some embodiments, a provided closure system includes a methodand apparatus for deployment of the closure system. Details of theclosure system, and uses thereof, are described herein, infra.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain features of a provided closure system are described in detailedherein below with reference to the figures, wherein:

FIG. 1 is a cross-sectional perspective view of an artery having anarterial closure device positioned on a closed arteriotomy, inaccordance with embodiments of the present invention;

FIG. 2 is a cross-sectional perspective view of the artery and arterialclosure device depicted in FIG. 1;

FIG. 3 illustrates a tapered suture assembly having a distal needle tipand a proximal bolster, in accordance with embodiments of the presentinvention;

FIG. 4 shows an alternative view of the suture assembly depicted in FIG.3;

FIG. 5 illustrates views of a bolster component, profiled to match thecurvature of an arterial surface, in accordance with embodiments of thepresent invention;

FIG. 6 is a cross-sectional side view of the artery and arterial closuredevice shown in FIGS. 1 and 2;

FIG. 7 is an end view of the artery and arterial closure device shown inFIGS. 1, 2, and 6;

FIG. 8 is a cross-sectional side view illustrating an arterial closuredevice positioned on a closed arteriotomy, in accordance withembodiments of the present invention;

FIG. 9 is an isometric view of an intra-arterial foot and wing, inaccordance with embodiments of the present invention;

FIG. 10 is an end view of the intra-arterial foot and wing shown in FIG.9;

FIG. 11 is an isometric view of a central core component of theintra-arterial foot shown in FIGS. 9 and 10;

FIG. 12 is an isometric view of a flexible wing component of theintra-arterial foot shown in FIGS. 9 and 10;

FIG. 13 is an isometric end view of the intra-arterial foot of FIGS. 9and 10 positioned within a delivery sheath;

FIG. 14 is an isometric side view of the intra-arterial foot of FIGS. 9and 10 positioned within a sectioned delivery sheath;

FIG. 15 is an isometric side view of the intra-arterial foot of FIGS.9-14 illustrating the flexible wing component folded within a deliverysheath;

FIG. 16 is an isometric side view of the intra-arterial foot of FIGS.9-14 illustrating the flexible wing component deployed when theintra-arterial foot is advanced through the delivery sheath into theartery;

FIG. 17 is an isometric view of the flexible wing component illustratinga central opening, in accordance with various embodiments of the presentinvention;

FIG. 18 is an isometric view of a profiled flexible wing componenthaving a plurality of openings for facilitating alignment of the centralcore component of FIG. 11, in accordance with other embodiments of thepresent invention;

FIG. 19 illustrates a plan view of one embodiment of the flexible wingcomponent of FIG. 12, having patterned holes and a non-porousmid-section;

FIG. 20 illustrates a plan view of another embodiment of the flexiblewing component of FIG. 12, having patterned slots and a non-porousmid-section;

FIG. 21 illustrates a plan view of another embodiment of the flexiblewing component of FIG. 12, having parallel slots and a non-porousmid-section;

FIG. 22 illustrates a plan view of yet another embodiment of theflexible wing component of FIG. 12, having parallel slots and non-porousmid-section;

FIG. 23 illustrates a plan view of yet another embodiment of theflexible wing component of FIG. 12, having profiled patterned holes andnon-porous mid-section;

FIG. 24 illustrates a plan view of yet another embodiment of theflexible wing component of FIG. 12, having profiled slots and non-porousmid-section;

FIG. 25 illustrates a plan view of yet another embodiment of theflexible wing component of FIG. 12, having patterned holes andnon-porous border around the edges;

FIG. 26 illustrates a plan view of another embodiment of the flexiblewing component of FIG. 12, having patterned holes and solid non-porousmid-section;

FIG. 27 is a plan view of an embodiment of the central core component ofFIG. 11;

FIG. 28 is an end view of the central core component of FIGS. 11 and 27;

FIG. 29 is an elevated cross-sectional view of the intra-arterial foot,illustrating the dimensions of the intra-arterial foot relative to anarteriotomy, in accordance with embodiments of the present invention;

FIG. 30 is an isometric view of another embodiment of an intra-arterialfoot illustrating the central core portion with a uniform thickness;

FIG. 31 is an end view of the intra-arterial foot of FIG. 30;

FIG. 32 is a side view of another embodiment of an intra-arterial footillustrating the central core portion having a circular profile withuniform thickness;

FIG. 33 is an end view of the intra-arterial foot of FIG. 32;

FIG. 34 is an end view of yet another embodiment of an intra-arterialfoot illustrating the central core portion having a circular profilewith varying thickness;

FIG. 35 is a bottom view of the intra-arterial foot of FIG. 34;

FIG. 36 is an end view of yet another embodiment of an intra-arterialfoot illustrating the central core portion having a circular profilewith varying thickness and hollowed sections;

FIG. 37 is a bottom view of the intra-arterial foot of FIG. 36;

FIG. 38 is an end view of yet another embodiment of an intra-arterialfoot illustrating the central core portion having a circular profile andvarying thickness;

FIG. 39 is a bottom view of the intra-arterial foot of FIG. 38;

FIG. 40 illustrates an isometric view of another embodiment of theintra-arterial foot, in accordance with embodiments of the presentinvention;

FIG. 41 is an end view of the intra-arterial foot of FIG. 40;

FIG. 42 illustrates an isometric view of another embodiment of theintra-arterial foot, in accordance with embodiments of the presentinvention;

FIG. 43 is an end view of the intra-arterial foot of FIG. 42;

FIG. 44 is illustrates an isometric view of yet another embodiment ofthe intra-arterial foot, in accordance with embodiments of the presentinvention;

FIG. 45 is an end view of the intra-arterial foot of FIG. 44;

FIG. 46 is illustrates an isometric view of yet another embodiment ofthe intra-arterial foot, in accordance with embodiments of the presentinvention;

FIG. 47 is an end view of the intra-arterial foot of FIG. 46;

FIG. 48 illustrates an isometric view of another embodiment of theintra-arterial foot, in accordance with embodiments of the presentinvention;

FIG. 49 is an end view of the intra-arterial foot of FIG. 48;

FIG. 50 illustrates top, front, side and isometric views of a needle, inaccordance with embodiments of the present invention;

FIG. 51 illustrates side, front, top and isometric views of a needle, inaccordance with embodiments of the present invention;

FIG. 52 illustrates side, front, top and isometric views of a needle, inaccordance with embodiments of the present invention;

FIG. 53 illustrates top, front, side and isometric views of a needlehaving a cylindrical profile, in accordance with embodiments of thepresent invention;

FIG. 54 illustrates top, front, side and isometric views of a needlehaving an elliptical profile, in accordance with embodiments of thepresent invention;

FIG. 55 illustrates side, front, top and isometric views of a needle, inaccordance with embodiments of the present invention;

FIG. 56 illustrates side, front, top and isometric views of a needle, inaccordance with embodiments of the present invention;

FIG. 57 illustrates an isometric view of a wound spreader and anintra-arterial foot attached to the distal end of a delivery device, inaccordance with embodiments of the present invention;

FIG. 58 is a side view of the delivery device of FIG. 57 positionedwithin a delivery sheath and having the distal end advanced into thelumen of an artery, in accordance with embodiments of the presentinvention;

FIG. 59 is a side view of the delivery device of FIGS. 57 and 58illustrating the wound spreader in a retracted position, engaging thewound edges of an arteriotomy;

FIG. 60 illustrates a perspective view of a wound spreader according toembodiments of the present invention;

FIG. 61 illustrates a perspective view of the wound spreader of FIG. 60from below the spreader;

FIG. 62 illustrates a bottom view of the wound spreader of FIG. 60;

FIG. 63 illustrates two isometric views of the distal end of a deliverydevice having first and second clips attached to the flexible wing ofthe intra-arterial foot of FIGS. 9 and 10;

FIG. 64 is an end view of a delivery sheath having spreader tangs forspreading the wound edges an arteriotomy;

FIG. 65 illustrates an isometric view of the delivery device of FIG. 64;

FIG. 66 is an isometric side view of a closure device attached to adelivery device, in accordance with embodiments of the presentinvention, with the closure device shown in cross section;

FIG. 67 is another isometric side view of the closure device anddelivery device of FIG. 66;

FIG. 68 is an isometric side view of the delivery device of FIGS. 66 and67, illustrating the needle drivers in an advanced position;

FIG. 69 is an isometric side view of the delivery device of FIGS. 66-68illustrating the ejection and release of the needle tip/suture assembly,in accordance with embodiments of the present invention;

FIG. 70 is an isometric bottom view of the intra-arterial foot of FIGS.8 and 9 with needles anchored to an underside portion of theintra-arterial foot;

FIG. 71 is a cross-sectional view of the intra-arterial foot of FIGS.66-70 illustrating a capture ribbon in a retracted position;

FIG. 72 is a partial cross-sectional view of a closure device positionedon an arteriotomy, in accordance with embodiments of the presentinvention;

FIG. 73 is an isometric view of a needle driver, with a needle/suturesubassembly attached thereto, advancing through an opening of a captureribbon component, in accordance with embodiments of the presentinvention;

FIG. 74 is an isometric view of the needle driver of FIG. 73 advancedthrough the opening of the capture ribbon component;

FIG. 75 is an isometric view of the needle/suture subassembly of FIG. 73deployed within the opening of the capture ribbon component;

FIG. 76 is an isometric view of the needle of FIG. 51, having a sutureattached thereto for forming a needle/suture subassembly, positioned ona distal end of a needle driver, in accordance with embodiments of thepresent invention;

FIG. 77 is an isometric view of an ejector pin ejecting theneedle/suture subassembly of FIG. 76;

FIG. 78 is an isometric view of the needle/suture subassembly of FIG.76, in accordance with embodiments of the present invention;

FIG. 79 is an isometric view of an ejector pin in position next to theneedle/suture subassembly of FIGS. 73 and 74, in accordance withembodiments of the present invention;

FIG. 80 is a cross-sectional view of the assembly illustrated by FIG.79;

FIG. 81 is a cross-sectional view of the needle/suture subassembly ofFIGS. 79 and 80 ejected from the needle driver;

FIG. 82 is an isometric view of the needle/suture subassembly of FIG.81;

FIGS. 83 and 84 are enlarged views of FIGS. 82 and 79, respectively;

FIGS. 85 and 86 are enlarged views of FIGS. 81 and 80, respectively;

FIG. 87 illustrates a needle assembly in accordance with embodiments ofthe present invention.

FIG. 88 illustrates the needle assembly of FIG. 87 during actuation;

FIG. 89 illustrates the needle assembly of FIG. 87 after ejection of asuture;

FIG. 90 illustrates a cross-sectional side view of the needle assemblyof FIG. 87;

FIG. 91 illustrates a cross-sectional side view of the needle assemblyof FIG. 87 ejecting a suture;

FIG. 92 illustrates an embodiment of a suture assembly in accordancewith embodiments of the present invention;

FIG. 93 illustrates a side view of the suture assembly of FIG. 92;

FIG. 94 illustrates the suture assembly of FIG. 92 with an alternativeshuttle in accordance with embodiments of the present invention;

FIG. 95 illustrates the suture assembly of FIG. 92 with yet anotheralternative shuttle in accordance with embodiments of the presentinvention;

FIG. 96 depicts a perspective view of the central core of anintra-arterial foot in accordance with embodiments of the presentinvention;

FIG. 97 shows a cross-sectional view of the central core depicted inFIG. 96;

FIG. 98 shows another cross-sectional view of the central core depictedin FIG. 96;

FIG. 99 illustrates a top view of the central core depicted in FIG. 96;

FIG. 100 illustrates a bottom perspective view of the central coredepicted in FIG. 96;

FIG. 101 provides a view of FIG. 100 from the opposite end of thecentral core;

FIG. 102 shows a bottom the central core of FIG. 96;

FIG. 103 shows a side view of the central core of FIG. 96;

FIGS. 104 and 105 illustrate end views the central core of FIG. 96;

FIG. 106 illustrates a central core prior to insertion of a ribbon wireengageable with a ribbon in accordance with embodiments of the presentinvention;

FIG. 107 illustrates the central core of FIG. 106 after insertion of theribbon wire;

FIG. 108 illustrates the central core of FIG. 106 after the ribbon wireengages the ribbon inserted into the central core;

FIG. 109 illustrates the central core of FIG. 106 prior to insertion ofan anchor assembly;

FIG. 110 shows a cross-sectional view of FIG. 109;

FIG. 111 illustrates a cross-sectional view of the central core shown inFIG. 106 with the ribbon inserted into the core and with the ribbon wireand anchor engaging the ribbon wire;

FIG. 112 illustrates a cross-sectional view of the central core shown inFIG. 106 during removal of a ribbon from the central core via the ribbonwire;

FIG. 113 illustrates a cross-sectional view of the central core shown inFIG. 106 after the ribbon has been removed from the core via the ribbonwire;

FIGS. 114-117 are perspective views of various embodiments of thecapture and release ribbon component, in accordance with variousembodiments of the present disclosure;

FIG. 118 is a perspective view of a capture and release ribboncomponent, in accordance with embodiments of the present invention; and

FIG. 119 is a cross-sectional view of the capture and release ribboncomponent of FIGS. 114-117 positioned within a sleeve, in accordancewith embodiments of the present invention.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS 1. General Description ofCertain Embodiments of the Invention

As described herein, the present invention provides a surgical closuresystem (also referred to herein as a “device”). As such, a provideddevice is useful for closing a perforation (i.e., a hole, puncture,tear, rip, or cut, etc.) in any hollow vessel associated with amammalian surgical procedure. One of ordinary skill in the art willappreciate that provided device is useful for closing a perforation inany lumen of a mammal, including the gastrointestinal tract (e.g., thestomach, intestines, colon, etc.), heart, peritoneal cavity, esophagus,vagina, trachea, bronchi, or a blood vessel.

Although certain figures and embodiments relate to use of a provideddevice for closure of a perforation associated with vascular surgery,one of ordinary skill in the art will appreciate that components of aprovided device are not size dependent (i.e., are scalable) and aretherefore useful for closure of any perforation in a lumen of a mammal.

In some embodiments, the present invention is directed to a closuresystem and method of percutaneous closure of an arteriotomy following anendovascular/intra-arterial procedures.

One of ordinary skill in the art will recognize that many mammalianlumina are comprised of one or more friable tissues. Thus, a commondifficulty associated with surgical closure of a perforation in suchlumina is that suture material typically causes tears in the friabletissue. Such tearing of the luminal tissue impedes healing and causesscarring. Indeed, such tearing of the friable tissues of the internallumina of blood vessels can lead to scarring, dislodgment of tissueparticles, blockage, or even eventual death of the patient. In view ofthe fragile nature of luminal tissues, an aspect of the presentinvention is to provide a device that affords dispersal of tension insuture material across the surface of a luminal tissue thereby allowingfor closure of a perforation with minimum damage to the tissue.

With regards to the arterial wall morphology, the fibrous adventitiallayer of an artery (i.e., the outer layer) is relatively tough, whilstthe intimal and endothelial layers are friable. Because of themorphology of the arterial wall, an arteriotomy will normally becircumferential in nature and perpendicular to the longitudinal axis ofthe artery. In accordance with the present disclosure, a providedintra-arterial-foot prevents trauma and/or damage to the friable innerlayer of the arterial wall by minimizing the amount of direct contactthe sutures have with the inner layer. In addition, the intra-arterialfoot distributes the tension in the sutures across the luminal surface.This closure configuration, i.e. controlling the alignment of the woundedges, and the absence of any transluminal impediments, ensures that thewound will heal expeditiously with minimal granulation tissue orscaring.

In certain embodiments, the present invention provides a closure systemand method of percutaneous closure of arteriotomies followingendovascular/intra-arterial procedures. In some embodiments, a closuredevice includes an intra-arterial foot positioned against a luminalsurface of an arteriotomy; at least one suture positioned within theintra-arterial foot for securing the intra-arterial foot into position,the at least one suture having a proximal end and a distal end; at leastone extra-arterial bolster attached to the proximal end of the at leastone suture, the at least one extra-arterial bolster secured on anadventitial surface of the arteriotomy; and at least one needle attachedto the distal end of the at least one suture, the at least one needleanchored on a posterior portion of the intra-arterial foot such that atensile force is applied to the suture, the suture securing theintra-arterial foot into position. In some embodiments, the suture isdoubled up within the intra-arterial foot. The at least one needledelivers the at least one suture through an arterial wall to a posteriorside of the intra-arterial foot. In some embodiments, the intra-arterialfoot, the suture, the bolster and the needle are all bio-absorbable.

In some embodiments, a closure device is comprising: a foot positionableagainst a luminal surface of an arteriotomy, the foot having an internalchannel; a suture positionable within the foot for securing the footagainst the luminal surface; and a bolster attached to a proximal end ofthe suture, the bolster positionable on an adventitial surface of thearteriotomy, the suture is fitted within the internal channel by atensile force applied to the suture. In certain embodiments, a provideddevice further includes a needle on a distal end of the suture. Theneedle guides the suture through the internal channel and to theposterior side of the foot. Moreover, the bolster tethers the footagainst the luminal surface in response to the tensile force. Eithersome or all of the components of this embodiment of the closure device,namely the foot, the suture and the bolster, is biodegradable.

As described in detail herein below, the closure system of the presentdisclosure includes two principal subassemblies, namely, a deliverydevice and a closure device. The delivery device is introduced via adelivery sheath that is already in situ after a given procedure. Thedelivery device delivers and positions the closure device in thearteriotomy, closing the arteriotomy. The closure device includes anintra-arterial foot component, tethering sutures, needle tips andextra-arterial bolsters. In accordance with the present disclosure, inthe final closure dynamic of the closure device, the intra-arterial footis positioned against a luminal surface juxtaposed to the arteriotomy ofa vessel. The sutures reside within an interference fit (e.g. a channel)of the intra-arterial foot, and secure the intra-arterial foot intoposition (i.e. against the luminal surface of the vessel). The bolstersare positioned on the adventitial or external surface of the artery andthe needle tips are positioned on the underside of the intra-arterialfoot and, in some embodiments, oblique to the intra-arterial footsurface to provide an anchor for the sutures.

The delivery device includes a foot anchor initially anchored to theintra-arterial foot during the delivery of the intra-arterial foot intothe internal lumen of the artery, a wound spreader for spreading thewound edges of the arteriotomy and needle drivers to drive theneedle/suture subassembly into a capture and release ribbon component.The capture and release ribbon components are adapted for tensioning thesuture securely within the channel in the intra-arterial foot and forreleasing the suture after the tensioning, in a manner described indetail herein below.

In one embodiment, the wound spreader component is oriented transverseto the artery and is positioned adjacent to the foot anchor. Inparticular, the wound spreader includes an elliptical configuration,with the major axis corresponding to an outermost diameter of theintra-arterial foot. In addition the major axis of the ellipticalconfiguration is at least the same as the circumference of the deliverysheath. During delivery of the intra-arterial foot, the wound spreaderaids the spreading of the wound edges of the arteriotomy, guiding thearteriotomy to conform to its elliptical configuration. Thus, the woundspreader controls the geometry of the arteriotomy, helping minimizeblood loss into the surrounding tissue.

In some embodiments, a provided closure system comprises a foot portion,a wing portion, a suture, one or more bolsters, and a needle/shuttle,and various combinations thereof. In certain embodiments, a providedclosure system further comprises a handle and deployment mechanism.Details of components associated with a provided closure system are setforth, infra, and, in certain embodiments, as depicted in theaccompanying Figures.

2. Components of a Provided Device

a. Foot

As used herein the term “foot”, used alone or in combination, forexample as “intra-arterial foot,” refers to a component of a providedclosure system that can act as an anchor for securing other componentsof the system. For example, a provided foot can secure a suture andsupport a wing component (described below). In certain embodiments, aprovided intra-arterial foot supports wound edges and minimizing theamount of direct contact the sutures have with a luminal surface of anartery. In some embodiments, a provided intra-arterial foot distributessuture tension across a luminal surface of an arteriotomy.

In some embodiments, a provided intra-arterial foot can be a tamponadefor controlling bleeding during a delivery of the closure device. Thearteriotomy includes a wound having at least two edges. Theintra-arterial foot helps maintain the two wound edges in apposition viathe suture assembly securing the foot in place with respect to the woundedges. The suture resides, and is substantially retained, within theintra-arterial foot and thus limits suture contact with the tissue inthe proximity of the arteriotomy.

In another embodiment, a provided foot includes a channel that locks thesuture into place. Alternatively, an interference fit between the sutureand the intra-arterial foot locks the suture into place.

In some embodiments, a provided foot includes a first portion having atleast one opening for facilitating delivery of a suture; and a flexiblesecond portion associated with the first portion, where the firstportion and the second portion create a tamponade effect on a wound(e.g., of an arteriotomy). The first portion is a central core componentfor providing structural integrity of the foot and the second portion isa flexible wing component. The suture tethers the first and the secondcomponent against a luminal surface of a vessel.

In some embodiments, a first portion of the intra-arterial foot includesa diameter that is less than a diameter of the arteriotomy and a secondportion includes a diameter that is greater than the diameter of thearteriotomy. In one embodiment, the first and the second portionsinclude an absorbable porous material, where the absorbable porousmaterial may include electrospun polyglycolic acid (PGA),polyglycolic/lactic acid (PGLA), Polyurethane (PUR) and polydioxanone(PDO). In other embodiments, the first and the second portions areradiopaque.

In certain embodiments, the first and the second portions have acircular configuration. In other embodiments, the first and secondportions are manufactured as a single component. In some embodimentswhere the first and the second portions have circular configurations,the first portion includes a uniform thickness and a flat profile.Alternatively, the first portion may include a circular profile anduniform thickness or varying thickness. In some specific embodiment, thefirst portion includes a circular profile and varying thickness havingat least one hollowed out portion.

In a second embodiment of the intra-arterial foot, the foot includes acentral core having at least one opening for facilitating delivery of asuture, the central core having a diameter less than a diameter of anarteriotomy; and a flexible wing associated with the central core, theflexible wing positionable on a luminal surface of an arteriotomy andthe flexible wing creating a tamponade.

The step of deploying the flexible portion of the foot includesdisposing the flexible portion from a substantially folded firstposition to a deployed second position. In one particular embodiment,the flexible portion of the foot is substantially larger than a diameterof the arteriotomy.

In one embodiment of the present disclosure, the intra-arterial footfunctions as a tamponade to control bleeding during the delivery of theclosure system. In addition, the intra-arterial foot protects thefriable intimal and endothelial layers of the artery from the sutures.In particular, the intra-arterial foot retains the suture substantiallywithin itself, thus limiting suture contact with any tissue in theproximity of the arteriotomy. In accordance with the present disclosure,the intra-arterial foot maintains the alignment of the arteriotomy woundedges and acts as a scaffold to accurately hold (and align) the woundedges into apposition during and after tightening of the sutures. Thatis, the intra-arterial foot in concert with the suture assembly bringsand maintains the two wound edges together in substantial alignment, asopposed to avert (i.e. turned out), invert (i.e. turned in) or overlapof the wound edges as the suture assemblies secure the foot in place.The apposition of the wound edges is advantageous to promote primaryintent wound healing (i.e. healing by first intention). As is wellknown, primary intent healing is full thickness healing which results inminimal scaring or granuloma within the healing wound. However, inaccordance with the present disclosure, direct apposition of the woundedges is not necessary for effective closure since apposition may notoccur in all instances due to many factors including, for example, thedisease state of the vessel.

Intra-arterial foot houses the sutures once tensioned. In particular,the sutures are partially positioned within a slot of the intra-arterialfoot in a folded manner such that each one is at least twofold withinthe intra-arterial foot. Moreover, the tensioned, folded suture occludesthe slot of the intra-arterial foot thereby assisting in the preventionof blood loss through the slots. The distal end of each of the suturesis attached to a corresponding needle tip and the proximal end isattached to a corresponding bolster. As such, the needle tip acts as ananchor to allow tensioning of the bolsters. More in particular, thesuture and bolster together securely tether the intra-arterial foot tothe luminal surface of the artery. The bolster, in particular,distributes a tensile force applied to the suture laterally across thearterial surface and parallel to the wound edges of the arteriotomy,thus ensuring an evenly distributed force along each wound edge of thearteriotomy to effect a secure closure of the arteriotomy as and afterthe wound edges are brought into apposition at least in part by theforce exerted through the bolster. Moreover, the intra-arterial footdistributes the resulting force of the suture tension on the luminalsurface of the artery. The distal needle tip is adapted to deliver thesuture through the arterial wall to the posterior side of theintra-arterial foot and to anchor the distal end of the suture to theintra-arterial foot. In particular, the distal end of the suture isattached to a central portion of the needle tip thus forming a “T”configuration.

Thus, the closure system of the present disclosure provides an activeand secure closure of wound edges of an arteriotomy. Healing of thearteriotomy is expedited because the wound edges are aligned and becausethe transluminal components are minimized and in some embodimentsnon-existent. Moreover, all friable tissues are shielded from anytension on the sutures. With regards to the sutures, the suture-basedclosure accommodates infinitely different anatomies. The closure systemexploits arterial wall morphology and uses the adventitial layer foranchoring. In the final closure dynamics, all intra-arterial componentsare tethered to arterial wall.

b. Wing

In certain embodiments, a provided device includes a flexible wingcomponent. In some embodiments, the wing is substantially circular. Incertain embodiments, the wing is elliptical. In certain embodiments, thewing is positionable against a provided foot for use as a woundoccluder. In such embodiments, the wing is positionable against aluminal surface and the foot is positionable against the internalsurface of the wing.

In one embodiment, the foot includes a flexible wing, the wing movablefrom a folded first position within a delivery device to a deployedsecond position within an artery. It will be appreciated that a flexiblewing component can be integrally formed with a provided foot or can be aseparate component used in conjunction with a provided foot.

In some embodiments, the second portion of the intra-arterial foot formsa seal with a portion of an arteriotomy. In addition, the second portionis adapted for movement between a first position substantially foldedabout the first component and a second position that is at leastpartially deployed. Alternatively, the second portion is adapted formovement from a substantially folded first position to a deployed secondposition. In particular, the second portion is at least partially foldedwithin a delivery sheath and at least partially open when the secondportion is advanced through the delivery sheath. In one embodiment, thesecond portion is elliptical in shape, where the second portion is widerin the latitudinal or transverse direction relative to a longitudinalaxis of the artery. In this particular embodiment, the minor diameter ofthe ellipse is larger than a diameter of the arteriotomy.

In some embodiments, a provided wing includes a plurality of patternedholes or, alternatively, slots and a midsection. In other embodiments, aprovided wing includes a plurality of latitudinal parallel slots and anon-porous midsection. In one particular embodiment, a provided wingincludes a plurality of longitudinal parallel slots and a midsection. Inanother particular embodiment, a provided wing includes a plurality ofprofiled patterned openings and a non-porous midsection. In yet anotherembodiment, a provided wing includes a plurality of profiled slots and anon-porous midsection. Alternatively, a provided wing may include aplurality of patterned holes and a non-porous border about an edgethereof. A provided wing having a plurality of patterned holes and asolid non-porous midsection is also envisioned.

c. Suture Bolster

As used herein, the term “bolster” refers to a device component attachedto a proximal end of a suture. The bolster ultimately is positioned atthe outer surface of the vessel for closure. For example, in the case ofan arteriotomy, a bolster is positionable at a fibrous adventitial layerof an artery (i.e., the outer layer).

In certain embodiments, an extra-arterial bolster is tethered to anadventitial surface of an arterial wall. In addition, the at least oneneedle is tethered to the intra-arterial foot and the intra-arterialfoot is tethered to the luminal surface of the arterial wall.

In accordance with the present invention, a tensile force is applied tothe suture, generating suture tension. In some embodiments, the suturetension effects active closure of the arteriotomy. In particular, theintra-arterial foot secures the suture in response to the tensile force.Moreover, the tension on the suture causes the extra-arterial bolster tosecurely tether the intra-arterial foot to the luminal surface layer ofthe artery. In one embodiment, the extra-arterial bolster distributesthe suture tension laterally across the arterial surface and parallel tothe at least two wound edges of the arteriotomy. In particular, theextra-arterial bolster evenly distributes the tensile force along eachof the plurality of wound edges of the arteriotomy to effect a secureclosure. In addition, the extra-arterial bolster distributes the suturetension on the adventitial surface of the artery with a resulting forcealigning the at least two wound edges. In one particular embodiment, thesuture tension on the adventitial surface of the artery results in aforce bringing the at least two wound edges into direct apposition. Theneedle-tip acts as an anchor in response to the suture tension such thattension is applied between the at least one extra-arterial bolster andthe intra-arterial foot.

In one particular embodiment, the method includes effecting, by thetensile force, closure of an arteriotomy. The tensile force tethers theat least one suture. In addition, the foot, which may include distinctwing and core components, helps seal and reinforce the arteriotomy inresponse to the tensile force.

d. Needle and Suture Shuttle

The needle, suture, and shuttle may take on various configuration invarious embodiments disclosed herein. Generally, the needle willreference the mechanism piercing and/or penetrating one or more of thevessel wall, the intra-arterial foot, and any ribbons disposed therein.The shuttle generally references the item attached to an end of thesuture. In some embodiments, the tip of a needle may be the shuttle, andhence may be attached to the suture. In other embodiments the shuttlemay be distinct from the needle and/or housed within, or on the needleand may be separated from the needle after penetrating theintra-arterial foot.

In one particular embodiment, the suture includes a tapered section. Inaddition, the suture is, inter alia, either a single monofilament or abraided suture. The suture, tapered or not, and the needle form a “T”configuration. In particular, the needle is rotatable to and from a “T”configuration with the suture. More in particular, the needle rotates toform a “T” configuration with the suture when the needle is ejected froma driving member.

The needle includes a body and a proximal spherical tip. The bodyincludes an opening for receiving a portion of the suture therewithin.In one embodiment, the opening includes a conical shape having a firstdiameter smaller than a second diameter, the smaller diameter securingthe suture. In another embodiment, the needle includes a shoulder andthe body includes a raised portion tapering from the shoulder to aproximal end of the needle. In this particular embodiment, the raisedportion is engageable with a slot within the driving member. Moreover,the raised portion is tapered to reduce the profile of the needle andthe suture.

In another embodiment, the needle includes a shoulder and a penetratingtip, where the shoulder is positionable on a distal portion of thedriving member. In this embodiment, the suture shelters behind theshoulder.

In yet another embodiment, the needle includes an elliptical profile. Inthis particular embodiment, the elliptical profile reduces a profile ofthe needle in a longitudinal axis. In addition, the elliptical profileincreases a surface area of the needle for securing the needle to theposterior side of the intra-arterial foot.

The needle includes a body having an opening for receiving a portion ofa suture; and a conical distal end attached to the body. A portion ofthe body and the conical distal end is tapered flat. In someembodiments, the needle includes one of an elliptical profile and acylindrical profile. Alternatively, the needle includes a flat edge. Theconical end includes a shoulder, the shoulder resting in a distalportion of a driving member. The conical end may sometimes include apenetrating tip. In one particular embodiment, the conical end of theneedle includes a shoulder and a penetrating tip, the shoulder restingon a distal portion of a driving member. In another embodiment, theconical end includes a raised portion tapering from the conical distalend to a proximal end of the body.

The needle drivers are positioned parallel to the foot anchor and areadvanced distally to drive the needle/suture subassembly through anopening of a capture and release ribbon component. The capture andrelease ribbon component captures the needle/suture subassembly andapplies a tensile force to move and secure the suture into the channelof the intra-arterial foot. The “T” configuration of the needle/suturesubassembly needle anchors the needle tip to the underside of theintra-arterial foot while the suture is secured within the channel.After the suture is secured within the channel, the ribbon componentreleases the suture and retracts into the delivery device.

3. Aspects of the Invention Embodied by the Figures

Other aspects, features and advantages of the presently disclosedclosure system and methods of percutaneous closure of arteriotomiesfollowing endovascular/intra-arterial procedures will become apparentfrom the following detailed description taken in conjunction with theaccompanying drawing, which illustrate, by way of example, the presentlydisclosed system and method.

Referring now to the drawing figures, wherein like references numeralsidentify similar, identical or corresponding elements, an embodiment ofthe presently disclosed closure system is described. The closure system,in accordance with the present disclosure, provides for a minimallyinvasive, percutaneous mechanical closure of arteriotomies, whilesubstantially reducing the length of time needed to perform the closure.

FIGS. 1 and 2 illustrate an exemplary closure device 100 in the finalclosure position with respect to an arteriotomy 202 of a sectionedartery 200. Closure device 100 includes an intra-arterial foot component102, tethering sutures 104, extra-arterial bolsters 106 and needle tips108. Closure device 100 is adapted for active and secure closure ofwound edges of an arteriotomy 202, in a manner described in detailherein below.

In some embodiments, the intra-arterial foot is a single-piece foot, asdepicted by foot 102. Foot 102 is tethered into position by twoindependent sutures 104, two extra-arterial bolsters 106, and two needletips 108. In particular, each suture 104 includes an extra-arterialbolster 106 attached to its proximal end and a needle tip 108 attachedto its distal end. During the delivery of closure device 100, the needletips 108 are inserted through an arterial wall 204 such that sutures 104penetrate the wall and pass through to the posterior side of thesingle-piece intra-arterial foot 102. Additionally, needle tips 108anchor the distal end of sutures 104 to an underside of intra-arterialfoot 102, in a manner described in detail herein below. As illustratedby the figures, when the sutures are situated in their final positionaccording to some embodiments of the present invention the two suturesare oriented in a mirrored configuration.

FIGS. 3 and 4 illustrate a suture 104 having a needle tip 108 on adistal end of suture 104 and a bolster 106 on the proximal end of suture104. Needle tip 108 and bolster 106 are attached to suture 104 usingtechniques well known in the art, such as, for example, bonding, using aglue/adhesive, heat staking, tying off the suture behind the particularcomponent, over-molding, or a combination of these processes. Suture 104is continuous between bolster 106 and needle tip 108. In accordance withembodiments of the present invention, bolster 106 secures the suture tothe arterial wall 204 and needle 108 secures the suture to theintra-arterial foot 102, thus securing intra-arterial foot 102 toluminal surface of the arteriotomy site. In particular, applying tensionto the suture 104 brings the wound edges 203 a and 203 b into alignmentand tethers the intra-arterial foot 102 to the lumen 206 of artery 200to effect closure of arteriotomy 202.

In some embodiments, suture 104 includes a regular section 105 a, atapered section 105 b and an enlarged section 105 c. Section 105 b istapered to increase the interference fit within the intra-arterial foot102, in a manner described in detail herein below. In some embodiments,suture 104 includes a single monofilament and tapered section 105 b maybe achieved by means of a bump-extrusion, coating or sleeve. In otherembodiments, suture 104 is a braided suture, where tapered section 105 bis attained by reducing the strands in the braid or by braiding over atapered mandrel. One method of anchoring the tensioned sutures withinthe intra-arterial foot 102 is by forming a channel 111 and by using aninterference fit between the suture and cavities (e.g. channel 111)within the intra-arterial foot 102 (FIGS. 9-11). The compression of theinterference fit can be increased by means of a tapered suture, asillustrated by FIG. 3. As discussed herein, some embodiments of thepresent invention incorporate a suture having a uniform thickness.

Suture 104 provides flexibility with respect to differing arterial wallthickness and other variations in anatomy. Additionally, suture 104infers variability of tensioned length, that is, suture 104 providesflexibility to all sizes of artery 200. By contrast, a purely mechanicalapplication of intra-arterial foot 102 would fit some arteries, but maybe excessively loose or tight on other arteries. Moreover, as suture 104is continuous, it does not require tying or cutting thus eliminating anextra process step. Also, the continuous suture 104 securely anchors theintra-arterial foot 102 to the luminal or internal surface 206 ofarteriotomy 202 in a fail-safe manner.

With reference to FIG. 5, in conjunction with FIGS. 3 and 4, bolster 106is attached to a proximal end of suture 104. The function of bolster 106is to securely tether intra-arterial foot 102 to the luminal layer 206of artery 200. In some embodiments of the present invention, bolster 106is designed to distribute a tensile force applied on suture 104 over alarge surface area and parallel to the wound edges 203 a and 203 b ofthe arteriotomy 202. Distributing the pressure resulting from thetension applied to the suture ensures that the adventitial or externalsurface 208 of artery 200 is not damaged. Furthermore, the tension inthe suture actively and securely brings the wound edges 203 a and 203 binto alignment with the intra-arterial foot to ensure proper alignmentof the opposing edges without requiring insertion of any foreignmaterial between the wound edges. As illustrated by the figure, bolster106 includes an opening 107 for receiving the proximal portion of suture104 and a profiled, arched section 109 for engaging the exterior surface208 of artery 200.

With reference to FIGS. 6 and 7, in conjunction with FIGS. 1 and 2,during closure of arteriotomy 202, needle tip 108 drives suture 104through a channel 111 within intra-arterial foot 102, in a mannerdescribed in detailed herein below with reference to FIGS. 64 and 65.Extra-arterial bolsters 106 are positioned on the adventitial surface208 of artery 200 by applying a tensile force on suture 104, which pullssuture 104 into channel 111 of intra-arterial foot 102 and secures theintra-arterial foot to lumen 206. As illustrated by the figures, suture104 is doubled up within the channel 111. As such, when tension isapplied to the suture 104 to position extra-arterial bolster 106 inplace, this tensing movement brings wound edges 203 a and 203 b intoalignment and maintains the alignment as channel 111 in intra-arterialfoot 102 locks sutures 104 into place.

With particular reference to FIG. 6, as bolster 106 makes contact withthe adventitial surface 208 of the artery 200 and tension is constantlyapplied to both sutures 104 they actively pull the edges 203 a and 203 bof arteriotomy 202 into alignment (depicted by the directional arrows),with the intra-arterial foot 102 providing a scaffold to ensure accuratealignment of the wound edges. This securely closes the arteriotomy andprovides the optimal closure for primary intent healing of thearteriotomy. It is noted that FIG. 6 illustrates bolster 106 in theirfinal position on the surface of artery 200, where the arteriotomy 202is effectively closed.

FIG. 8 describes an alternative configuration with respect to thedistribution of the suture tension to affect an active closure of thearteriotomy 202. In this particular embodiment, the basic configurationof closure device 100 is similar to that shown in FIGS. 1 and 2;however, the sutures within intra-arterial-foot 102 include the bolstersattached to the proximal ends, but do not include the needle-tips. Asshown by the figures, a bolster is attached to the proximal end of eachsuture and the distal end of each suture resides within intra-arterialfoot 102. An interference fit between suture 104 and intra-arterial-foot102 secures the sutures to maintain tension on each one of theextra-arterial bolster 106. It is noted that the sutures 104 do notcontact the inner lumen surface except for at the point of penetrationor transluminal tissue across the arteriotomy in some embodiments,thereby eliminating the risk of damaging the tissue around the incisionsite due to point loading of a suture directly contacting the tissue. Insome embodiments, the folded suture loops may be pulled through anopening at the top of the foot and out of arteriotomy. Although theclosure device in the embodiment shown in FIG. 8 does not include aneedle tip, embodiments of the present invention include a needle tipthat guides the suture into place. In such embodiments, the needle tipis maneuvered through the delivery shaft and removed from the distal endof the suture.

The materials used in the components of the presently disclosed closuresystem generally include materials that are bioabsorbable. In thefollowing description, any details regarding specific materials are forexemplary purposes only and are not intended to be limiting. Therefore,it is to be understood that the recitation of any material or materialproperty in this disclosure is not to be limited to those precisematerials or properties.

Suture 104 may be a standard polyglycolic acid (PGA), polydioxanone(PDO) or a polyglycolic/lactic acid (PGLA) 9010 copolymer. Monofilamentand multifilament sutures may be utilized. Alternatively, suture 104 maybe composed of many off the shelf absorbable suture. However, it isnoted that the material should allow the suture to be flexible.

Bolster 106 may be manufactured from the same absorbable material assuture 104. In one particular embodiment, for example, the material is ablend of 82:18 PLA/PGA or a blend of 15% 5050 DLG 1A and 85% of 8218 LG13E. In other embodiments, bolster 106 may be a standard PGA, PGLA,Polyurethane (PUR) and polydioxanone (PDO).

With reference to FIGS. 9-12, another embodiment of intra-arterial foot102 will now be described in detail. In this particular embodiment,intra-arterial foot 102 is a two-piece foot having two functionalelements, namely a central core component 110 and a flexible wing 112.In accordance with the present disclosure, flexible wing 112 foldswithin a delivery sheath for ease of delivery of intra-arterial foot 102into the lumen of the artery 200.

FIGS. 11 and 12 illustrate each of the two components of intra-arterialfoot 102, with FIG. 11 illustrating central core component 110 and FIG.12 illustrating flexible wings 112.

Flexible wing 112 increases the surface area of the intra-arterial footcontacting the inner surface of an artery and hence, increases thetamponade effect of intra-arterial foot 102. As such, bleeding fromarteriotomy 202 is increasingly controlled during the delivery andsecuring of the closure device 100. Central core component 110 providesintra-arterial foot 102 with additional structural integrity.Additionally, central core 110 facilitates the delivery of sutures 104and maintains the engagement of the sutures after tensioning of thesutures. In particular, as shown by FIG. 9 and particularly FIG. 11,central core component 110 includes a plurality of openings or slots forreceiving sutures 104. More particularly, needles 108 are ejected fromtheir driving member and pass through channel 111. Providing flexiblewing 112 separate and independent from the central core component 110further facilitates the longitudinal flexibility of flexible wing 112.

With reference to FIGS. 13-16, a method of delivering the intra-arterialfoot 102 of FIGS. 9-10 is described. During delivery of the two-pieceintra-arterial foot 102, flexible wing 112 is folded to fit within aprocedural or delivery sheath 150. Upon exiting delivery sheath 150,flexible wing 112 intrinsically spreads open during deployment. FIGS. 15and 16 illustrate isometrically the flexible wing folded within deliverysheath 150 and opened once the intra-arterial foot 102 is advancedthrough the delivery sheath 150 into artery 200. After exiting thedelivery sheath, at least a portion of the delivery device,automatically or under direct control of the operator, is partiallyretracted thereby positioning wing 112 of foot 102 on the inner lumensurface directly below the arteriotomy site. In embodiments including awound spreader, this retraction may place the wound spreader within thearteriotomy, thereby shaping the wound as discussed further below andassisting with the occlusion of the wound to provide a hemostaticeffect. In concert with the wound spreader shaping and occluding thearteriotomy the deployed flexible wing 112 creates a tamponade on thearteriotomy 202, immediately controlling arterial bleeding. As such,flexible wing 112 takes advantage of hydraulic forces within artery 200to create a seal as the foot in its entirety is secured in place. It isnoted that the intrinsic opening of wings 112 is by way of the elasticproperties of the wing materials.

In other embodiments, flexible wing 112 may be actively spread, oncedeployed from the delivery sheath 150, by applying tension to suturesthat are attached to the lateral extremities of wing 112. In thisparticular embodiment (not shown by the figures), the lateral sutureswould also retract the lateral wound edges 203 a, 203 b of arteriotomy202 during applied tension to the structures. Controlling thepositioning of the wound edges 203 a, 203 b in this manner issignificant in (1) aiding the tamponade of the winged intra-arterialfoot, (2) facilitating the ability to accurately deploy the needle 108and suture system 104 relative to the controlled position of the woundedges, and (3) centralizing the device relative to the arteriotomy 202.Mechanically, positioning the wound edges once the delivery sheath 150has been removed from the arteriotomy has particular relevance to largearteriotomies (e.g. above 10 French units), which loose their intrinsicability to contract the wound edges.

With reference to FIG. 63, an alternative to actively spreading flexiblewing 112 and retracting wound edges 203 a and 203 b is illustrated. Inthis particular embodiment, the stored energy in a spring clips 308 isused to spread wing 112. Spring clips 308 may be, for example, astainless steel wire or a nitinol clip. In some embodiments, each springclip 308 is flexible enough to allow flexible wing 112 to fold withindelivery sheath 150, actively spread the wing and simultaneously retractthe lateral edges of arteriotomy 202. Each clip 308 is attached toeither side of flexible wing 112, as illustrated by the figure. Clips308 may be released from flexible wing 112, after intra-arterial foot102 is implanted about arteriotomy 202, by pulling clips 308 in anupward direction relative to the plane of the intra-arterial foot 102,and using arterial wall 204 to provide counter traction to allow clip308 to release from flexible wing 112 wing spreader recess. Clip housing309 houses the proximal end of each clip 308, leading and aiding thecontrol the movement of the clips 308 during the pulling action. In someembodiments, clips 308 are adapted for spreading the wound edges of thearteriotomy.

With reference to the embodiment shown in FIG. 12, the geometry of wing112 is elliptical in shape, i.e. wider in the latitudinal or transverseto the longitudinal axis of the artery. In some embodiments, the minordiameter of the ellipse is larger than the diameter of the arteriotomyby at least (π)×(diameter)/2. This particular dimensioning of wing 112is necessary to form an effective seal. Typically, arteriotomy 202 isformed by progressive dilation. In addition, and as a consequence of themorphology of arterial wall 204, the arteriotomy is generally of atransverse nature, and hence the width of the arteriotomy (in itsnatural state) is given by (π)×(diameter)/2, where “diameter” is theouter diameter of the dilator (not shown by the figures) used to createthe arteriotomy. An elliptically shaped wing oriented with its majordiameter transverse to the longitudinal axis of the artery offers anadvantageous seal over a circular profile with respect to the transversenature of the arteriotomy since the material needed to create the sealis reduced. That is, although a circular wing could create a seal, alarger surface area would be required.

As shown in FIG. 12, wing 112 may be curved in profile to match theprofile of the lumen of artery 200. Alternatively, wing 112 may be flat(FIGS. 31-39) to increase its shape memory (i.e. spring-back).

Wing 112 may include a central opening 126 (FIG. 17), which may becircular to allow the wing to freely rotate independent of the footcore. Alternatively, wing 112 may include a plurality of openings 128(FIG. 18) that correspond to a plurality of openings in central core 110(not shown) in a specific alignment.

The flexibility of wing 112 is not just important in a lateralconfiguration to facilitate collapse during delivery (FIGS. 13-16), butit is also important to have flexibility in a longitudinal plane.Flexibility in both lateral and longitudinal planes is important forsome embodiments to ensure an effective tamponade of arteries indiffering disease states with different surface topographies and varyinganatomical configurations. Independent flexibility in different planesmay be achieved with elastomeric materials such as polydioxanone,polyurethane films, or by very thin films produced by extrusion, solventcasting, or compression molding, etc. Wing geometry, perforations,slots, etc. can also be utilized to infer independent flexibility indifferent directions. It is also advantageous that the wing be porous insome embodiments to allow nutrient exchange to the luminal surface 206of artery 200, whilst maintaining sufficient tamponade effect. Thisfacilitates blood coagulation on the wing surface and creates a seal.

FIGS. 19-26 illustrate various embodiments of different types of wingdesigns to increase the flexibility and the porosity of wing 112, inaccordance with various embodiments of the present invention. Withparticular reference to FIGS. 25 and 26, the solid broader silhouette129 is designed to stiffen the wing's perimeter to prevent the potentialof the wing to folding-back-on-itself during deployment within theartery 200 and during the natural blood flow of the artery. It is notedthat porosity of the wing may also be achieved by use of absorbableporous materials, such as, for example, electrospun Polyglycolic acid(PGA) or the addition of soluble materials to the polymer duringprocessing.

With reference to FIGS. 27-29, in conjunction with FIGS. 9 and 10,central core component 110 may be circular in geometry and of a higherstiffness, relative to wing 112. In some embodiments, central corecomponent 110 is sized to be less than the diameter of the arteriotomy202 (FIG. 29). This ensures that central core component 110 fitscomfortably within the delivery sheath 150. As illustrated by FIG. 29,central core component 110 may include a curvature for suiting theluminal curvature of the artery (see, for example, FIG. 7). Thiscurvature imparts an elliptical surface area on central core component110, similar to wing 112, with a major diameter transverse to thelongitudinal axis of artery 200. The shape of central core component 110(equivalent to that of wing 112) helps to ensure wing 112 unfolds whendeployed from within the delivery sheath 150. Additionally, the shape ofcentral core component 110 supports flexible wing 112 once positionedagainst the arterial lumen 206 and helps to prevent wing 112 fromfolding back on itself during deployment.

With continued reference to FIG. 29, central core component 110 includesa diameter “L” that is smaller than the arteriotomy 202 and the outsidediameter “OD” of delivery sheath 150. Moreover, flexible wing 112includes a diameter larger than the arteriotomy 202 and the outsidediameter of delivery sheath 150. In such embodiments, and as describedherein, flexible wing 112 is deployable from a folded first position toa deployed second position.

FIGS. 30-39 illustrate alternative embodiments of central core component110 and flexible wing 112. These embodiments illustrate central corecomponent 110 and wing 112 as circular in the plan view. Central corecomponent 110 and wing 112 may include the same material. Moreover, wing112 is independent from central core component 110, where wing 112 islarger than the diameter of arteriotomy 202 and central core component110 is smaller than the diameter of arteriotomy 200.

With reference to FIGS. 40-49, alternative embodiments of intra-arterialfoot 102 are illustrated. In these embodiments, intra-arterial foot 102is a single piece configuration (i.e. central core component 110 andwing 112 are one unit) manufactured from one material. These embodimentsillustrate designs that are circular in the plan view. The outerdiameter of the intra-arterial foot 102 of FIGS. 40-49 is larger thanthe diameter of arteriotomy 202. This design concept requires that theintra-arterial foot material be elastomeric so that, the one pieceintra-arterial foot can be deformed during insertion into the deliverysheath and will open out to its original diameter without any plasticdeformation, once deployed within the artery. By way of example, for an18 French arteriotomy, these designs would typically have anintra-arterial foot diameter of 10 mm in the plan view.

In accordance with embodiments of the present invention, closure device100 is bio-absorbable. In particular, closure device 100 has afunctional requirement with structural integrity in the order ofapproximately 1 to 100 days to allow clinical healing of the arterialwall and absorption should be complete within approximately 1 to 300days. As known in the art, complete absorption is defined as less thanapproximately 10% of the original mass.

In some embodiments, material for the intra-arterial foot is the samefor both the flexible wing and the central core to ensure consistent,more predictable biocompatibility and ease of manufacturing. Thesematerials are required to be both haemocompatible and biocompatible insome embodiments. The materials may be non-absorbable, however, thepreferred material would be synthetic absorbable polymer. Selection ofthe appropriate absorbable material is based on haemocompatibility,biocompatibility functional and physical characteristics and absorptionprofile.

The haemo- and biocompatibility requirements of the material, inaccordance with embodiments of the present invention, include, but arenot limited to materials that do not cause adverse tissue reaction,haemolysis, and severe thrombogenesis or occluding emboli formation.During absorption of the material, the breakdown products from theabsorbable material should not result in producing emboli, which wouldcause downstream occlusion. This is achieved by surface erosion whichproduces particles of less than 8 (to allow them to pass through acapillary bed), or by encouraging encapsulation of the intra-arterialimplant to anchor all fragmented particles from the absorbing implant tothe arterial wall 204.

Moreover, the functional and physical characteristics of the materialshould allow elastic deformation of the flexible wing (to allow it tofold within the delivery sheath 150 and conform to the luminal surfaceof the artery once delivered), and provide sufficient strength,stiffness or rigidity to the central-core to allow correct positioning,suture capture and locking during the delivery process.

In one particular embodiment, the absorption profile should allowstructural integrity of the implant for at least 20 days to allowclinical healing of the arterial wall 204 and absorption should becomplete within approximately 90 days, in which time the arterial wallwill have completely remodeled to its original condition. Completeabsorption is defined as less than 10% of the original mass.Intra-arterial foot 102 may be manufactured with bio-degradable plasticand elastomeric materials such as, for example, PGA, PGLA, PUR and PDO.

In one particular embodiment, the intra-arterial foot 102 is radiopaquesuch as to locate intra-arterial foot 102 in situ, after implantation bymeans of a radiograph or fluoroscopy or other x-ray imaging modality.Radiopacity of the intra-arterial foot can be achieved by the additionof contrast agents to the polymer such as, for example, barium sulphate.An alternative method is to incorporate the addition of an absorbableradiopaque metal alloy such as, for example, bioabsorbable magnesiumalloy.

In accordance with embodiments of the present invention, intra-arterialfoot provides numerous advantages over the prior art. For example,flexible wing 112 allows the sealing component of intra-arterial foot102 to fold for delivery. In addition, flexible wing 112 allows largesurface area sealing member (greater than the diameter of thearteriotomy) to be delivered into the artery for effective tamponade ofthe arteriotomy. Moreover, the flexible and independent wing 112 allowsthe sealing member to conform to the topology of the arterial luminalsurface. Furthermore, flexible wing 112 may be made from porous materialto aide nutrient exchange to the luminal surface beneath the wing.Because flexible wing 112 is wider in the latitudinal plane, it reducesthe surface of the sealing member without compromising the effectivenessof the seal. Moreover, an active wound retraction (on the lateral edges)controls the wound edges position for better control of bleeding,ensuring the intra-arterial foot 102 is centrally aligned relative tothe arteriotomy, and increases the distance from the wound edge to thesuture penetration point.

The central core component 110 facilitates both delivery and securing ofthe closure device. In addition, the central core component 110 incircular plan-view profile aids in supporting the flexible wing withinthe artery, to ensure the wings 112 unfold and help to prevent fold-backof the wings. Moreover, intra-arterial foot 102 can be made fromabsorbable material, leaving no permanent implant once healing iscomplete.

With reference to FIGS. 50-56, needle tip 108 includes a body portion130 having a proximal spherical end 132. In accordance with someembodiments of the present invention, needle tip 108 and suture 104 forma “T” configuration (See, for example, FIG. 75). In particular, theproximal spherical end 132 facilitates rotation of the needle tip 108 toand from the “T” configuration with suture 104 upon ejection from itsdriver (not shown). Body portion 130 includes an opening 134 forreceiving a portion of suture 104 therein. In one particular embodiment,opening 134 is conical with a first diameter substantially smaller thana second diameter, where the first diameter is adjacent to the sutureside so as to increase security of the attached suture 104. As discussedherein, suture 104 may be secured to body portion 130 by conventionalmeans including adhesives, bonding, etc.

With continued reference to FIGS. 50-56, in one embodiment, needle tip108 includes a shoulder 136 and a penetrating tip 138 (FIGS. 51, 55 and56). In this particular embodiment, shoulder 136 is adapted such that itrests on a distal portion of a driving member (i.e. the deliverysystem). In other embodiments, the distal end of needle tip 108 includesa penetrating tip 138 but no shoulder (FIGS. 50, 52 and 53). In yetother embodiments, the body portion 130 includes a raised portion 140tapering from shoulder 136 to a proximal end of needle tip 108 (FIGS. 51and 56). In this particular embodiment, raised portion 140 is designedto engage with a slot within a needle driver 312 (FIGS. 70, 71 and 73)to prevent needle tip 108 from rotating relative to the driver 312 anddamaging suture 104. Moreover, raised portion 140 may taper to reducethe profile of both the needle and the emanating suture duringpenetration. Thus, suture 104 is permitted to shelter behind shoulder136. In some embodiments, needle 108 includes a cylindrical profile(FIG. 53). In other embodiments, needle 108 includes an ellipticalprofile (FIG. 54). The elliptical profile reduces the needle profilealong the long axis to provide increased surface area for securing theneedle tip on the posterior side of the intra-arterial foot 102. Inother embodiments, needle 108 includes a cylindrical profile having aflat edge (FIG. 55). In yet other embodiments of needle tip 108 includesshoulder 136 and body portion 130 includes a flat edge (FIG. 56).

With reference again to FIGS. 15 and 16, in conjunction with FIGS. 1 and2, a method of use and operation of closure system 100 will be describedin detail. Closure system 100 is positioned on a distal end of adelivery system 300 and advanced within the lumen of artery 200 via adelivery sheath 150. As illustrated by FIG. 15, flexible wing 112 ofintra-arterial foot 102 is folded within delivery sheath 150 and isdeployed as it emerges from delivery sheath 150 within the lumen ofartery 200 (FIG. 16). Intra-arterial foot 102 is tethered in position bytwo independent sutures 104 and bolsters 106. Each suture 104 includes abolster 106 at its proximal end and a needle 108 at its distal end. Inaccordance with the present disclosure, delivery system 300 drivesneedle 108, and therefore suture 104, to move distally in a straight,linear pathway through arterial wall 204. Such movement drives needletip 108 (and suture 104), through intra-arterial foot 102 and is ejectedon the posterior side of intra-arterial foot 102. A shear force is thenapplied to suture 104, pulling sutures 104 into a channel 111 withinintra-arterial foot 102 and generating a tensile force within thesuture. The tensile force in suture 104 secures the intra-arterial foot102 on the luminal surface 206 of artery 200. This tensile forceadditionally pulls bolsters 106 against the adventitial surface 208 ofartery 200. Moreover, needle tips 108 are anchored against the posteriorsurface of intra-arterial foot 102 in response to the applied tension onthe sutures 104. The tension applied to the sutures 104 bring about aclosure of the arteriotomy 202. In particular, bolsters 106 distributethe tension on the suture such that the wound edges 203 a and 203 b arebrought into alignment and/or apposition. Delivery system 300 is thenremoved leaving behind the secured closure system 100 with arteriotomy202 sealed by the intra-arterial foot 102.

With reference to FIGS. 66 and 67, an exemplary delivery device andmethod will now be described in detail. Delivery device 300 includesgenerally a wound spreader, a ribbon capture and release component and aneedle driver having an ejection pin. As already described herein above,the closure device 100, in accordance with the present disclosure, isattached to the distal end of the delivery device 300 and is driven intoposition via a delivery sheath 150. When the intra-arterial footcomponent 102 exits procedural sheath 150, it opens, spreading open toeffect a tamponade affect of the intra-arterial foot 102 to controlarterial bleeding (FIGS. 15 and 16). In one embodiment, the spreading ofintra-arterial foot 102 is a result of the elastic properties ofintra-arterial foot 102. In an alternative embodiment, intra-arterialfoot 102 may be actively spread, once deployed from the proceduralsheath, by applying tension to spring clips 308, which are attached tothe lateral extremities of the flexible wings 112 (FIG. 63). Clips 308attached to a lateral flexible wing 112 performs a second importantfunction of retracting the lateral wound edges 203 a and 203 b ofarteriotomy 202.

Typically, dilated arteriotomies are configured in a circumferentialorientation, transverse to the longitudinal axis of artery 200. Thus,applying lateral traction to the wound edges 203 a, 203 b of arteriotomy202 has the effect of bringing the wound edges towards apposition. Inaccordance with the present disclosure, a wound spreader componentcontrols the positioning of the wound edges 203 a, 203 b aids thetamponade of flexible wings 112 of intra-arterial foot 102. Thispositioning of wound edges 203 a and 203 b helps to facilitate theability to accurately deploy needle 108 and sutures 104 relative to thecontrolled position of wound edges 203 a and 203 b. Furthermore, itcentralizes the closure device 100 relative to the arteriotomy.

With reference to FIGS. 57-59, a portion of an exemplary delivery device300 is illustrated, in accordance with one embodiment of the presentdisclosure. Delivery device 300 includes a foot anchor 358 and a woundspreader component 304 adjacent to foot anchor 358. Delivery device 300is adapted for delivering closure device 100 for closing wound edges 203a and 203 b of an arteriotomy 202, in a manner described in detailherein below.

In some embodiments, wound spreader component 304 includes a flexiblemember forming an elliptical profile. The spreader component 304 may beoriented in the direction relevant to the appropriate or desired woundretraction. In some particular embodiments, the major diameter of woundspreader 304 may be substantially the same as the outermost diameter ofintra-arterial foot 102. Moreover, the major diameter of wound spreader304 may be substantially the same diameter as the diameter of deliverysheath 150. In other embodiments the major diameter of the woundspreader is substantially larger than the diameter of delivery sheath150. In such embodiments, the compressible nature of the spreader allowsthe spreader to fit within the sheath.

With continued reference to FIGS. 57-59, foot anchor 358 is releasablyattached to intra-arterial foot 102. More specifically, foot anchor 358anchors intra-arterial foot 102 during its delivery and positioningagainst the arteriotomy. As illustrated by these figures, wound spreader304 is adjacent to foot anchor 358, wherein a distal end of the woundspreader 304 is substantially abutting a portion of intra-arterial foot102. Thus, when the closure system of the present disclosure is used inarterial application, wound spreader 304 helps minimize blood loss intothe surrounding soft tissues. In particular, when the introducer sheath150 is removed from artery 200 prior to deploying the intra-arterialfoot 102, spreader component 304 functions as a temporary seal, prior tosecuring the intra-arterial foot on the arteriotomy. As delivery sheath150 is removed from the arteriotomy, the arteriotomy conformssubstantially to the geometry and shape of wound spreader 304.

With reference to FIGS. 58 and 59, in operation, wound spreader 304 andintra-arterial foot 102 are advanced through delivery sheath 150 andinto the lumen of an artery. Wound spreader 304 and foot anchor 358 arethen retracted proximally such that the wound spreader 304 controls thewound edges 203 a and 203 b of arteriotomy 202 and intra-arterial foot102 is positioned against the internal wall of the artery. A needlehousing (not shown), housing needle drivers and positioned withindelivery sheath 150, is then positioned against the exterior wall of theartery. Once intra-arterial foot 102 is positioned in the internalsurface of the arterial lumen 206 juxtaposed with arteriotomy 202, a“sandwich” is created, wherein arterial wall 204 is held betweenintra-arterial foot 102 and the needle housing (FIG. 59).

In accordance with the embodiment illustrated by FIGS. 29, 59, and 68the intra-arterial foot is held in its correct position against theinternal arterial surface (i.e. internal wall), centrally locatedrelative to the arteriotomy. Additionally, the needle/suture subassemblyand needle driver assembly 312 have unobstructed and direct passagethrough arterial wall 204 into intra-arterial foot 102.

Wound spreader component 304 may be manufactured from a semi compliantmaterial such that it can deform to fit within delivery sheath 150during delivery through the percutaneous tissue (not shown by thefigures) and into arterial lumen 206. Once positioned in arterial lumen206, wound spreader 304 is exposed distally relative to delivery sheath150 and is deployed to its initial profile. Delivery sheath 150 is thenwithdrawn until the delivery sheath is no longer within the arteriotomy,and is replaced by the geometry of wound spreader 304. As such,arteriotomy 202 moves from a first geometry (e.g. circular) to a secondgeometry (e.g. elliptical) to conform to the shape of spreader component304. It is noted that bleeding is controlled during this withdrawal andtransition between geometries by the tamponade of both delivery sheath150 and spreader 304.

FIG. 60 illustrates a perspective view of a wound spreader according toembodiments of the present invention. The wound spreader 601 is amagnified view of wound spreader 304 depicted in FIG. 57. Like woundspreader 304, wound spreader 601 may be incorporated with the anchorassembly of a delivery device. The spreader assists with spreading thewound edges and additionally assists in minimizing blood loss into thesurrounding soft tissue when the introducer sheath of the deliverydevice is removed from the artery, but prior to the intra-arterial footbeing secured in place. In some embodiments, the spreader occupiessubstantially the entire wound space once the sheath is removed. Sheath601 is geometrically designed such that the shoulders 603 of thespreader are spread further apart than the neck 602 of the spreader. Theincreased width of the spreader in the shoulder region is designed to besubstantially as wide as the diameter of the introducer sheathdelivering an intra-arterial foot in some embodiments. The width of thespreader maintains a lateral tension in a wound such that the edges ofthe wound, for example edges 203 a and 203 b shown in FIG. 2, are drawncloser together. By occupying the space of the wound and by drawing theedges of the wound together the wound spread helps minimize fluid flowthrough the wound. The shape of the wound spreader may be an ellipticalshape, and the spreader may be composed of a compressible material.

FIG. 61 illustrates a perspective view of the wound spreader of FIG. 60from below the spreader, and FIG. 62 illustrates a bottom view of thewound spreader of FIG. 60. As demonstrated in FIGS. 61 and 62, spreader601 may include arcuate edges 604 and 615, conforming to the shape ofthe wing of the intra-arterial foot. Edges 604 and 615 may recede todifferent depths into respective surfaces of the spreader such that face611 of the spreader is at an angle or taper. Additionally, the woundspreader generally includes an opening 610, which provides a passagewaythrough which an object such as a foot anchor, ribbons or other objectsinteracting with the intra-arterial foot may pass. The spreader isgenerally coupled to an extension of the anchor assembly 606 at the neck602 of the spreader in a co-axial alignment. In some embodiments theaxial extension 606 of the anchor assembly is coupled to an interiorregion of spreader 601. In other embodiments, the extension may becoupled to an exterior portion of the anchor assembly. However, asdemonstrated, the extension 606 and spreader 601 maintain a passagewayfor entry and exiting of various elements.

With reference to FIGS. 64 and 65, an alternative method of spreadingand orienting wound edges 203 a, 203 b is illustrated wherein deliverydevice 300 includes spreader tangs 310 having a length and a distal endpositioned on a side portion of delivery sheath 150. In this particularembodiment, delivery sheath 150 is a tri-lumen extrusion (not shown): alarge inner lumen for providing access to various surgical instrumentsand delivery device 300, and two smaller lumens for housing spreadertangs 310. During delivery, spreader tangs 310 are retracted back insideprocedural sheath 150. Once positioned inside artery 200, tangs 310 areadvanced out to the front end of delivery sheath 150 then sprungoutwardly such that once they exit distally from delivery sheath 150,the distance between them would be greater than the distance betweenthem when contained inside delivery sheath 150. This added width assiststo actively retract and spread the wound edges 203 a and 203 b.

In one embodiment, tangs 310 include a floppy, atraumatic tip at thedistal end. An atraumatic tip ensures that tangs 310 are advanced intointernal lumen 206 like guide wires, with minimal trauma to the lumenduring delivery and use. The length of tangs 310 eliminates the risks oftangs 310 accidentally being pulled out of arteriotomy 202 during thespreading and orientation of wound edges 203 a and 203 b. In otherembodiments, tangs 310 include a mating feature for securing them toprocedural sheath 150 such that when tangs 310 exit from the front endof sheath 150, their orientation is fixed to one plane, not free torotate. This configuration ensures that tangs 310 apply traction towound edges 203 a and 203 b in the transverse plane only.

With reference now to FIGS. 66-68, delivery device 300 further includesneedle drivers 312 for driving needle 108 and suture 104 throughintra-arterial foot 102. Each needle driver 312 includes an ejector pin,such as pin 314 depicted in FIG. 77, contained within needle driver 312for disengaging the needle/suture (FIGS. 69 and 77). In someembodiments, needle tip 108 is adapted to be re-oriented from a firstconcentric alignment with needle driver 312 to a second horizontalposition once free from driver 312. More in particular, and as describedherein above, needle tip 108 forms a “T” configuration with suture 104.

With particular reference to FIGS. 67 and 68, in conjunction with FIGS.73 and 74, after the intra-arterial foot 102 is in position, needledrivers 312 are advanced through the arterial wall and a portion of theintra-arterial foot to drive the needle/suture subassembly to aposterior side of the intra-arterial foot. More in particular, FIG. 68illustrate needle divers 312 in an advanced position passing through aprofiled opening 316 of a capture and release ribbon component 313(component 313 shown in FIGS. 73 and 74). As shown in various figures,including FIGS. 66-69 and 71, the delivery device may deploy a pair ofribbons 33 through the channel in the intra-arterial foot. The distalend of the ribbons, particularly tab 315, may project in opposingdirections, such that one ribbon forms an acute angle with respect tothe anchor and sheath and the other ribbon forms an obtuse angle withrespect to the sheath. In some embodiments, the acute angle is about 40degrees. In certain embodiments, the obtuse angle is about 140 degrees.Once needle/suture subassembly passes through opening 316 on tab 315 ofribbon 313, ejector pin 314 ejects the needle tip 108 (FIG. 69). Afterejecting needle tip 108, each needle driver 312 and ejector pin 314 areretracted from the intra-arterial foot 102 (i.e. moved in a proximaldirection) into the needle housing. Moreover, each needle tip 108 has alength substantially larger than any diameter of the profiled opening316 of capture ribbon component 313. Thus, once needle tip 108 isejected from needle driver 312 through profiled opening 316, the needletip 108 cannot be removed back because of its dimension. Thus, suture104 remains threaded through the profile opening 316 of capture ribbons313 (FIG. 75). Furthermore, once a significant amount of the sutureextends beyond the capture ribbon, the suture may have enough slack toensure that the shuttle does not slip back through the hole in thecapture ribbon. Accordingly, some embodiments of the present inventionmay be provided without a T configuration.

With reference to FIGS. 70-72, and FIGS. 73-75, delivery device 300further includes at least two capture and release ribbon components 313extending laterally for capturing, retracting and locking the deployedneedle/suture subassembly. Capture and release ribbon component 313includes a first longitudinal portion attached to a movable mount (notshown) and a second tab portion 315 extending from the firstlongitudinal portion. Second tab portion 315 includes the profiledopening 316. As described hereinabove, profile opening 316 is adaptedfor receiving and engaging the needle/suture subassembly.

Second tab portion 315 further includes a lock ribbon (e.g. an aperture)(not shown) for receiving and locking a longitudinal member for holdingthe intra-arterial foot in place during the driving of the needle/suturesubassembly.

In operation, during actuation of delivery system 300, each needledriver 312 advance distally to drive each needle/suture subassemblythrough arterial wall 206, intra-arterial foot components and throughprofile opening 316 of capture and release ribbon component 313 to aposterior side of intra-arterial foot. Each ejector pin 314 then ejectsshuttle-suture subassembly 108 a out through the side of needle driver312 leaving the shuttle-suture subassembly remaining threaded throughcapture ribbons 313 (FIG. 75). In one embodiment, the timing of thismovement could be configured to retract driver 312 and partially retractcapture ribbon 313 back up through the center of intra-arterial foot102.

With particular reference to FIG. 71, the second tab portion of captureand release ribbon component 313 are moved laterally channel 111 ofintra-arterial foot 102 in response to a longitudinal retraction of thefirst longitudinal portion of capture ribbons components 313. Thisretracting action pulls a portion of the suture/needle subassembly intochannel 111. The re-oriented needle tip 108 acts as an anchor and abutsagainst the underside and edge of intra-arterial foot 102 (FIG. 70). Asnoted above, some embodiments of the present invention may be providedwithout a T configuration and the suture slack may be relied upon toprevent the shuttle from slipping back through the hole in the captureribbon. Once needle 108 is effectively stationary (i.e. blocked fromfurther travel), suture 104 connected to extra-arterial bolster 106outside artery 200 will continue to pull into the artery 200 as captureand release ribbon component 313 continue to retract into channel 111.This action will also pull extra-arterial bolster 106 down onto theexternal surface 208 of artery 200 (FIG. 72). As illustrated by FIGS. 71and 72, retraction of ribbon components 313 will pull suture 104 intochannel 111 and double suture 104 on itself. More in particular, suture104 is partially pulled into the space (i.e. channel 111) previouslyoccupied by the retracting ribbon capture components 313.

More in particular, and with continued reference to FIGS. 71 and 72,when capture and release ribbons component 313 pull the needle/suturesubassembly, needle 108 is secured against a surface of intra-arterialfoot 102 while suture 104 is doubled-up and secured within channel 111of intra-arterial foot 102. Because the distal end of suture 104 (i.e.needle 108) is anchored against intra-arterial foot 102, when ribboncomponent 313 is retracted, a portion of suture 104 is advanced (i.e.pulled) and doubled within channel 111. This action creates aninterference fit between suture 104 and channel 111 of intra-arterialfoot 102. FIG. 72 illustrates intra-arterial foot 102 implanted inartery 200 with doubled up sutures 104 tethered into position, needletips 108 anchored against the intra arterial foot, and external bolster106 tightened onto the outer wall (i.e. external surface 208) of artery200.

To accommodate variations in arterial morphology and wall thicknessdimensions between patient populations, it is envisioned that thecapture and release ribbon components 313 will disengage from suture 104after the suture is positioned within channel 111 and/or when apredetermined load is reached. It is noted that the release will not bereached until the interference lock with the doubled up suture 104 a isreached on both sides of intra-arterial foot 102. In view of thevariations in arterial morphology the interference lock with the doubledup suture may be reached at various points in different patients or invessels with different thicknesses and more arterial tissue with respectto other vessels.

With reference to FIGS. 76 and 77, in conjunction with FIG. 51, oneembodiment of needle/suture subassembly is illustrated attached to adistal end of a driver 312. In this particular embodiment, needle tip108, with suture 104 attached thereto, punctures the vessel wall duringan operation and penetrates the foot and ribbons. This embodiment alsoincorporates a keying feature, which engages with a slot in the needledriver tube. This feature ensures orientation of the needle-tip andsuture relative to the needle driver and prevents damage to the sutureor suture/needle junction during assembly, deployment and ejection. Theramped back profile on the needle tip is designed to allow room for thesuture to fold down to protect it from any shearing action during thefiring through arterial wall and intra-arterial foot 102. Folding of thesuture should also help to minimize the penetration force when passingthrough the arterial wall.

With reference to FIGS. 79-86, one embodiment of a needle-shuttle-suturesubassembly attached to a distal end of pusher 314, in accordance withthe present disclosure, is described. In the particular embodimentillustrated in FIGS. 79-86, pusher 314 is pointed to engageneedle-shuttle suture subassembly 108 b having a puncturing tip. Inoperation, pusher 314 is advanced to deploy through arterial wall 206and into a recess (i.e. channel 111 within intra-arterial foot 102.During this actuation, pusher 314 and needle-shuttle/suture subassemblyalso pass through capture and release ribbon component 313 housed inintra-arterial foot 102, as described herein above with reference, forexample, to FIGS. 74 and 75.

FIG. 87 illustrates a needle in accordance with embodiments of thepresent invention. The needle demonstrates an embodiment that may beused as an alternative to the needle embodiments demonstrated in FIGS.73, 76, and 79. The needle embodiment depicted in FIG. 87 may be used incombination with various delivery system embodiments of the presentinvention. The needle design depicted in FIG. 87, like the embodimentshown in FIGS. 76 and 79 engage a suture configured to extend axiallyfrom the needle. However, the needle embodiment depicted in FIG. 87 hasa tubular needle 870 that is distinct and detachable from suture 872.Needle tube 870 may be ejected from the sheath of a delivery system,thereby piercing the vessel wall of an artery. Because the suture 872 isengaged with the needle 870 via shuttle 871 attached to suture 872, thesuture will enter the vessel wall as the needle pierces the wall, in amanner similar to a thread attached to a sewing needle piercing a pieceof fabric.

FIG. 88 illustrates the needle of FIG. 87 during actuation. After needle870 has penetrated a vessel wall, carrying suture 872 and shuttle 871with it through the wall, pusher rod 880 may be translated through thehollow tube of needle 870 to eject and hence detach the suture andshuttle from the needle tube 870.

As demonstrated in FIG. 89 pusher rod 880 may extend beyond the tip ofneedle 870 to effect complete ejection and detachment of suture 872 andshuttle 871 from needle 870. During an operating procedure, once thesuture penetrates the vessel wall and is detached from the needle, theneedle may be withdrawn from the artery. As previously demonstrated theneedle may be aligned within the sheath of the delivery system so thatit will penetrate a portion of the intra-arterial foot. In someembodiments, the needle penetrates a portion of the intra-arterial footand a ribbon engaged with the foot through coaxially aligned aperturesin the foot and ribbon. Accordingly, once the shuttle and suture arereleased from the needle and the needle is extracted, the shuttle andsuture remain engaged with the foot and ribbon. The shuttle will assistin anchoring the suture to the intra-arterial foot when the suture ispulled taught.

FIG. 90 illustrates a cross-sectional side view of the needle of FIG.87. As indicated above and depicted in FIG. 90, the engagement ofshuttle 871, which is attached to suture 872, with tubular needle 870,maintains the attachment of the suture to the needle and assures thatthe suture is pulled through any surfaces that the needle penetrates.The pointed edge of the tubular needle assist the needle in piercing anextra-arterial surface.

FIG. 91 illustrates a cross-sectional side view of the needle of FIG. 87ejecting a suture. As shown the ejection of the suture is effected bythe interaction of the pusher rod 880 with the shuttle 871 attached tosuture 872.

FIG. 92 illustrates an embodiment of a suture assembly in accordancewith embodiments of the present invention. The suture assembly depictedin FIG. 92 is engageable with various needle assembly embodiments.Unlike the suture assembly depicted in FIGS. 3 and 4, the sutureassembly depicted in FIG. 92 includes a shuttle that is co-axial withthe extended suture 921. The assembly includes a bolster 922 positionedalong the suture 921. Bolster 922, although generally stationary, may bemovably attached to the suture in some embodiments so that when theshuttle and suture are inserted into a vessel and an intra-arterial footvia a needle and ejected from the needle, the bolster 922 may beadjusted to contact the exterior surface of the vessel and fixed on thesuture at a location that maintains the suture taught and thereby holdsthe intra-arterial foot in place.

FIG. 93 illustrates a side view of the suture assembly of FIG. 92. Asdemonstrated the shuttle 920 is tapered in accordance with variousembodiments of the present invention. However as demonstrated in FIGS.94 and 95, the shuttle may take on other geometric shapes andproperties. Specifically, the shuttle may have a uniform cross section,such as the tubular cross-section depicted by shuttle 940 of FIG. 94 andthe cylindrical cross section depicted by shuttle 950 of FIG. 95. Asfurther demonstrated by FIGS. 94 and 95, shuttles according toembodiments of the present invention may be hollow like shuttle 940 ormay be solid like shuttle 950. A hollow shuttle or partially hollow,such as shuttle 940, allows the suture to be knotted and the knot may bemaintained within the shuttle while keeping the suture affixed to theshuttle. The shuttle may be fixed to the suture through various meanssuch as by knotting or tying of the suture, by bonding, using aglue/adhesive, by heat staking, by over-molding, or a combination ofthese processes. In some embodiments the shuttle may be movable, atleast temporarily, along the suture.

FIG. 96 depicts a perspective view of the central core of anintra-arterial foot in accordance with embodiments of the presentinvention. Central core 960 may be coupled with a wing according tovarious embodiments of the present invention. Core 960 includes variousapertures engageable for delivery of the core to a vessel and forcoupling the core to a vessel via sutures. Core 960 has a centralopening 961. Opening 961 does not extend through the bottom side of core960. Opening 961 allows the foot to be anchored to an anchor assembly aswill be further discussed. Opening 961 may be shaped to correspond tothe base of an anchor such that the base of the anchor fits in core 960in a lock and key configuration (i.e. the shape of the anchor base maycorrespond to at least a portion of the opening. Core 960 also includesopenings 962 and 963, which receive the needle, suture, and shuttleprovided by embodiments of the present invention. Each of openings961-963 may be tapered or angled in accordance with various embodimentsof the present invention. The angular aspect of opening 961 allows core960 to be maintained at a particular orientation on the base of ananchor. Core 960 also includes a channel 964 extending through the core.

FIG. 97 shows a cross-sectional view of the central core depicted inFIG. 96. As shown in FIG. 97 channel 964 may extend an entire span ofcore 960. As further demonstrated in FIG. 96, core 960 may includeopenings 970 and 971, which may be aligned with parts of opening 961.

FIG. 98 shows another cross-sectional view of the central core depictedin FIG. 96. As shown in FIG. 98, the region on core 960 directly belowthe center of opening 961 is solid such that a portion of the openingdoes not penetrate the entire depth of core 960.

FIG. 99 illustrates a top view of the central core depicted in FIG. 96.While a central region of opening 961 may not penetrate the entire depthof core 960, other opening such as opening 971 may provide a channelaligned with opening 961 such that the channel penetrates the entiredepth of core 960. FIG. 99 further demonstrates an exemplary shape ofcore 960 in accordance with various embodiments of the presentinvention.

FIG. 100 illustrates a bottom perspective view of the central coredepicted in FIG. 96. FIG. 100 shows openings 962 and 963 as penetratingthe entire depth of core 960. As described above, these openings receivethe shuttle portion of suture assemblies via the insertion of needlesinto the openings.

FIG. 101 provides a view of FIG. 100 from the opposite end of thecentral core. Channel 964 shown on one side of core 960 in FIG. 100 isshown to extend to the other side of core 960 in FIG. 101.

FIG. 102 shows a bottom view the central core of FIG. 96. The perimeterof the core 960 is illustrated as having a distinct geometry on thebottom of core 960 that differs from the geometry on the top of core960.

FIG. 103 shows a side view of the central core of FIG. 96. The topsurface of core 960 may not be planar as demonstrated in FIG. 103.Additionally, the entry/exit point of openings 970 and 971 may be offsetfrom opening 961 such that a channel extending from one of openings 971or 970 to opening 961 is angular with respect to core 960.

FIGS. 104 and 105 illustrate end views the central core of FIG. 96 withchannel 964 extending from one end to the other end. As discussed withprevious embodiments, in some embodiments the core may have an arcuateupper surface to conform to an intra-arterial surface.

FIG. 106 illustrates a central core prior to insertion of a ribbon wireengageable with a ribbon in accordance with embodiments of the presentinvention. In accordance with some embodiments of the present invention,a single ribbon 1061 may be engaged with a central core 960 of anintra-arterial foot. The ribbon, which may be used to affix one or moresutures to central core 960 in a prescribed manner, such as the mannerillustrated by sutures 104 in FIG. 1, is engageable with ribbon wire1060. Engaging ribbon wire 1060 with ribbon 1061 requires insertingribbon wire 1060 into opening 961 before inserting ribbon 1060completely in channel 964.

FIG. 107 illustrates the central core of FIG. 106 after insertion of theribbon wire into opening 961 in preparation to receive ribbon 1061through the loop formed by wire 1060. Ribbon 1060 includes grooves 1062configured to engage and maintain engagement with ribbon wire 1060.

FIG. 108 illustrates the central core of FIG. 106 after the ribbon wireengages the ribbon inserted into the central core. As shown in FIG. 106wire 1060 engages grooves 1062 of ribbon 1061 according to variousembodiments of the present invention. Additionally openings 963 and 962are aligned with openings 1101 and 1100 of ribbon 1060. The alignment ofthe openings on ribbon 1060 and core 960 allows penetration of needleassemblies and suture assemblies according to various embodiments of thepresent invention.

FIG. 109 illustrates' the central core of FIG. 106 prior to insertion ofan anchor assembly. The anchor assembly 1090 may be moved axially, theassembly travelling parallel to the ribbon wire. Anchor assembly mayinclude prongs 1091 geometrically shaped to fit in a keyed portion ofopening 961.

FIG. 110 shows a cross-sectional view of FIG. 109. As shown in FIG. 109,ribbon 1061 may include a plurality of apertures, engageable withvarious components of the delivery device and securing members, such asthe suture assemblies. Openings 1100 and 1101 are aligned with openings962 and 963 in core 960.

FIG. 111 illustrates a cross-sectional view of the central core shown inFIG. 106 with the ribbon inserted into the core and with the ribbon wireand anchor engaging the ribbon wire. The prongs of the anchor assembly1091 traverse openings 1102 and 1103 of ribbon 1061 as well as openings970 and 971 in core 960, thereby helping to maintain the core of theintra-arterial foot anchored to the anchor assembly for movablydeploying the foot from a sheath through an arteriotomy and into theinterior of an artery or vessel.

FIG. 112 illustrates a cross-sectional view of the central core shown inFIG. 106 during removal of a ribbon from the central core via the ribbonwire. In the context of an operation, once sutures are deployed andextend through apertures 1101 and 1100 of ribbon 1061 and apertures 963and 962 of core 960 and core 960 is positioned as desired, anchorassembly 1090 and ribbon wire 1060 may be retracted. The retraction ofthese components may occur independently of one another. The retractionof ribbon wire 1060 will cause ribbon 1061 to be drawn out of core 960through central opening 961. As shown in FIG. 112, ribbon 1061 may bemade sufficiently flexible, via material and/or geometric properties, toachieve such a withdrawal. As apertures 1101 and 1100 are withdrawn fromcore 960 they will pull any suture extending there through towards thecenter of the core 960, whereby the sutures may become affixed withinchannel 964 of core 960.

FIG. 113 illustrates a cross-sectional view of the central core shown inFIG. 106 after the ribbon has been removed from the core via the ribbonwire. As the ribbon wire is retracted further, the ribbon 1061 may becompletely removed from core 960 through opening 961. The sutures may becut in accordance with some embodiments in order to allow completewithdrawal of the ribbon from core 960. However, as discussed furtherbelow, the ribbon may be configured to release the sutures extendingthrough the apertures of the ribbons without cutting the sutures.

With reference to FIGS. 114-118, after suture 104 is positioned withinchannel 111, in a manner described hereinabove, capture and releaseribbon component 313 will disengage and release suture 104. In someembodiment, the disengagement of suture 104 from capture and releaseribbons 313 may be a cutting action. In other embodiments, thedisengagement of suture 104 involves a release mechanism 317 wherein thesuture loop is knocked off from ribbon component 313. In particular, thedisengagement and release of sutures 104 will occur at an exit hole on aportion of intra-arterial foot 102. Following release of suture 104,capture and release ribbon components 313 will retract completely fromclosure device 200.

With continued reference to FIGS. 114-118, various embodiments of therelease mechanism 317 of ribbon components 313, in accordance with thepresent disclosure, are illustrated. Release mechanism 317 may be, forexample, a cut detail, which allows ribbon 313 open and/or un-link fromthe captured suture 104. In one particular embodiment, capture ribbon313 includes a laser cut nitinol ribbon with a fold out tab folding onitself and extendable in the longitudinal direction (FIGS. 114, 116 and117).

With reference for FIG. 119, ribbon component 313 is illustrated withina sleeve having a cut-out portion. The cut-out portion is adapted forallowing release mechanism 317 to release suture 104 in the event thatthe suture is not release by the methods described hereinabove. Inparticular, when the ribbon component pulls the suture, the load on therelease mechanism 317 will cause the release mechanism to deploy openthus releasing the suture. The cut-out portion on the sleeve, asillustrated by the figure, will ensure that the suture is released whenthe suture attempts to pass through the sleeve, since the suture willapply an increased load on the mechanism 317 until the mechanismreleases the suture. The sleeve is no longer retaining the captureribbon loop.

Capture and release ribbon component 313 is a flexible member forpermitting movement in and retraction from intra-arterial foot 102. Inone embodiment, capture and release ribbon components 313 may bemanufactured from a flexible but non-compliant plastic material, suchas, for example, Polyether ether ketone (PEEK) or a metal such as, forexample, nitinol or stainless steel.

While FIGS. 1-119 illustratively describe exemplary components of theexemplary closure system, according to specific embodiments of thepresent invention, it is to be understood that a person ordinarilyskilled in the art can readily modify the demonstrated system consistentwith the above descriptions. For example, although the closure system100 is described herein as application to the an artery, it is theintent of the present disclosure that the closure system describedherein will also apply to other applications, such as, for example,NOTES SILS and the closure of many surgically induced openings. Itshould therefore be recognized that the present disclosure is notlimited to the specific embodiments illustrated herein above, but ratherextends in utility to many other modification, variation, application,and embodiment, and accordingly, all such modifications, variations,applications, and embodiments are to be regarded within the scope of thepresent disclosure.

4. Uses and Procedures

As described generally above, a provided device is useful for closing aperforation (i.e., a hole, puncture, tear, rip, or cut) in any hollowvessel associated with a mammalian surgical procedure. One of ordinaryskill in the art will appreciate that provided device is useful forclosing a perforation in any lumen of a mammal, including thegastrointestinal tract (e.g., the stomach, intestines, colon, etc.), theheart, the peritoneal cavity, or a blood vessel.

In some embodiments, a provided device is useful for closing aperforation (i.e., a hole, puncture, tear, rip, or cut) in any hollowvessel associated with a human surgical procedure. In some embodiments,a provided device is suitable for closing a perforation in a veterinarysurgical procedure. In certain embodiments, a veterinary surgicalprocedure is an equine surgical procedure.

In one embodiment, the closure system is adapted for percutaneousclosure of an arteriotomy following endovascular/intra-arterialprocedures. Although the closure system is described as one directed tothe closure of an arteriotomy of the common femoral artery or vein, theclosure system described herein is equally applicable to closure ofopenings in any membrane, wall, septum or vessel. Similarly, althoughthe closure system of the present disclosure is for large holearteriotomy (in the size range of approximately 10 to approximately 30French units), closure system 100 is equally application to smaller holeranges (e.g. approximately 5 to 10 French units). One particularapplication of the presently described closure system is of the closureof remote openings during minimal invasive surgery, such as, forexample, Natural Orifice Transluminal Endoscopic Surgery (NOTES),closure of the visceral surface being crossed and the closure of patentforamen ovale.

One of ordinary skill in the art will appreciate that a variety ofsurgical procedures result in a perforation in a lumen of the patient.In some embodiments, the surgical procedure is SILS (single incisionlaparoscopic surgery, also known as “belly-button surgery”), NOTES, orlaparoscopic surgery.

In some embodiments, the present invention is directed to a closuresystem and method of percutaneous closure of an arteriotomy following anendovascular/intra-arterial procedures.

A method of closing an arteriotomy is also described. The methodincludes advancing a closure system into a lumen of an artery, theclosure system including a foot, at least one suture, at least onebolster attached to a proximal end of the at least one suture, and aneedle/shuttle attached to a distal end of the at least one suture;deploying a flexible portion of the foot within the lumen of the artery;driving the needle through the foot to a posterior surface of the foot;and applying a tensile force on the at least one suture, the at leastone bolster is secured against a adventitial surface of the artery inresponse to the tensile force and the foot is secured against a luminalsurface of the artery in response to the tensile force. At least one ofthe foot, the suture, the bolster and the needle are bio-degradable. Themethod further includes anchoring the needle/shuttle against theposterior surface of the foot in response to the tensile force. Inaddition, the method further includes aligning, by the intra-arterialfoot, at least two wound edges of an arteriotomy. In one embodiment, thefoot is secured against a luminal surface of the artery in response tothe tensile force. In addition, the foot forms a seal with a portion ofthe arteriotomy.

We claim:
 1. A method of closing an arteriotomy the method comprising:advancing a closure system into a lumen of an artery, the closure systemincluding a foot, at least one suture positioned within the foot, atleast one bolster attached to a proximal end of the at least one suture,and a needle attached to a distal end of the at least one suture;deploying a flexible portion of the foot within the lumen of the artery;driving the needle through a wall of the artery and through the foot toa posterior surface of the foot; and applying a tensile force on the atleast one suture, wherein the at least one bolster is secured against anadventitial surface of the artery in response to the tensile force andfurther wherein the foot is secured against a luminal surface of theartery.
 2. The method of claim 1, further comprising anchoring theneedle against the under surface of the foot in response to the tensileforce.
 3. The method o of claim 1, further comprising aligning, by theintra-arterial foot, at least two wound edges of an arteriotomy.
 4. Themethod of claim 1, wherein the foot is secured against a luminal surfaceof the artery, thereby sealing the arteriotomy, in response to thetensile force.
 5. The method of claim 1, further comprising effecting,by the tensile force, closure of an arteriotomy.
 6. The method of claim1, further comprising tethering, by the tensile force, the at least onesuture.
 7. The method of claim 1, wherein each of the foot, the suture,the bolster and the needle are bio-degradable.
 8. The method of claim 1,wherein deploying the flexible portion of the foot includes disposingthe flexible portion from a substantially folded first position to adeployed second position.
 9. The method of claim 1, wherein the step ofdriving the needle includes ejecting the needle through an aperture of acapture ribbon component, the capture ribbon component engaging aportion of the suture.
 10. The method of closing an arteriotomy asrecited in claim 9, further comprising retracting the capture ribbon.11. The method of closing an arteriotomy as recited in claim 10, whereinretracting the capture ribbon results in pulling the suture into achannel of intra-arterial foot, and wherein retracting the captureribbon leads to a tensile force applied to the suture.
 12. The method ofclosing an arteriotomy as recited in claim 11, wherein the tensile forcesecures the intra-arterial foot against an internal surface of thelumen.
 13. The method of closing an arteriotomy as recited in claim 11,wherein the tensile force effects active closure of the arteriotomy. 14.The method of closing an arteriotomy as recited in claim 11, wherein thetensile force causes the at least one bolster to securely tether theintra-arterial foot to an internal wall of the artery.
 15. The method ofclosing an arteriotomy as recited in claim 10, wherein retracting thecapture ribbon doubles the suture to form a loop within the channel ofthe intra-arterial foot.
 16. The method of closing an arteriotomy asrecited in claim 11, further comprising disengaging the capture ribbonfrom the suture.
 17. A closure system comprising: a closure deviceincluding a foot, at least one suture having a distal end and a proximalend, at least one bolster attached to the proximal end and a needleattached to the distal end, the closure device adapted for closing anopening of a vessel; and a delivery device for delivering the closuredevice into a lumen of the vessel, the delivery device including: awound spreader; at least one capture ribbon component, the at least onecapture ribbon component includes a profiled opening; and a needledriver for driving the needle through the profiled opening of thecapture ribbon component and a portion of the foot, to a posterior sideof the foot; wherein the capture ribbon component engages a portion ofthe suture; and wherein a portion of the suture is pulled within achannel of the foot when the capture ribbon engages the suture.
 18. Theclosure system of claim 17, wherein the at least one capture ribboncomponent includes a first longitudinal portion attached to the movablemount and a second tab portion extending from the first longitudinalportion, and wherein the second tab portion engages a portion of thesuture when the capture ribbon component is retracted.
 19. The closuresystem of claim 17, wherein the closure device is attached to a distalend of the wound spreader;
 20. The closure system of claim 17, whereinthe wound spreader includes an elliptical profile.
 21. The closuresystem of claim 17, wherein the needle driver includes at least oneejector pin for ejecting the needle from the needle driver, wherein theneedle is deployed from a first position parallel to a longitudinal axisof the proximal end of the suture to a second position significantlyperpendicular to the longitudinal axis of the proximal end of the suturewhen is ejected from the driver, and wherein the needle is anchored toan underside portion of the foot when the portion of the suture ispulled within a channel.
 22. The closure system of claim 17, wherein thecapture ribbon component applies a tensile force to the at least onesuture for generating suture tension, wherein the suture tension effectsactive closure of the opening of the vessel, and wherein the suturetension secures the bolster to an external wall of the vessel.